jonathan emord

05 Sep: FDA Must Withdraw NDI Guidance or Extend Comment Period to July 2012

By James J. Gormley In our August 23rd post, we alerted you to a U.S. Food and Drug Administration (FDA) draft guidance on “new” dietary ingredients. We recommended that our 100,000+ members ask the FDA to withdraw the guidance and to not adopt the policies underpinning the interpretation behind this “guidance” in its review and enforcement activities. In the meantime,…

16 Jun: The FDA: A Warning Letter From American Taxpayers

By James J. Gormley From American Chronicle In June 2007, the U.S. Food and Drug Administration (FDA) issued the final rule on Current Good Manufacturing Practices (cGMPs), which, according to Nutraingredients-usa.com, is regarded by many as “the most important regulatory development for the dietary supplement industry in over a decade.” Vasilos Frankos, Ph.D, outgoing director of the FDA’s Division of…